Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccines mRNA-1647 and mRNA-1443 in Healthy Adults

Therapuetic Areas:Other
Age Range:18 - 49
Start Date:November 13, 2017
End Date:July 2020
Contact:Moderna Clinical Trials

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A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccines mRNA-1647 and mRNA-1443 When Administered to Healthy Adults

This clinical study will assess the safety, reactogenicity and immunogenicity of mRNA-1647
and mRNA-1443 cytomegalovirus vaccines in healthy adults

Inclusion Criteria:

- Agrees to comply with the study procedures and provides written informed consent

- 18 to 49 years of age

- Body mass index between 18 and 35 kg/m2

- In good health based on medical history, physical examination, vital sign measurements
and laboratory safety tests performed prior to initial study vaccination

- Negative urine pregnancy test at the Screening visit and the day of each vaccination
for females of childbearing potential

- Female subjects must either be of non-childbearing potential or use acceptable methods
of contraception from at least 30 days prior to enrollment and through 3 months
following last vaccination

- Male subjects must agree to practice adequate contraception for 30 days prior to the
first vaccination and through 3 months following the last vaccination

- Willing to comply with the requirements of the protocol (eg, complete Diary Cards,
return for follow-up visits, be available for safety phone calls)

Exclusion Criteria:

- Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care

- A history of malignancy in the last 10 years

- If female and of childbearing potential, is pregnant or lactating, has not adhered to
an adequate contraception method from at least 30 days before study entry, or does not
plan to do so for at least 3 months after the last vaccination.

- Abnormal screening safety laboratory test results including liver enzyme tests

- Administration of any investigational or non-registered product (drug or vaccine)
other than the study vaccine within 30 days preceding the first dose of study vaccine
or has plans for administration during the study period

- Prior administration of investigational agent using lipid nanoparticle formulations

- A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or
human immunodeficiency virus types 1 or 2 antibodies

- A positive test result for drugs of abuse

- Chronic administration of potentially hepatotoxic drugs or have other medical
conditions that affect the liver (eg, alcohol abuse)

- A history of idiopathic urticaria

- Plans for administration or has been administered a vaccine within the period from 30
days before through 30 days after each study vaccination, with the exception of any
licensed influenza vaccine administered ≥15 days before or after any study vaccination

- Any chronic administration of an immunosuppressant or other immune modifying drug

- Prior administration of immunoglobulins and/or any blood products within the 3 months
before the first study vaccine or has plans for administration during the study period

- Any known or suspected immune-mediated disease or immunosuppressive condition as
determined by medical history and/or physical examination

- A history of hypersensitivity or serious reactions to previous vaccinations

- Any bleeding disorder considered a contraindication to IM injection or blood draw

- Any acute illness or fever at screening

- Any condition that, in the opinion of the investigator, would pose a health risk to
the subject if enrolled or could interfere with evaluation of the study drug or
interpretation of study results

- Dose-escalation phase only, is seropositive for CMV at the Screening visit

- Donation of blood or blood products > 450 mL within 30 days of dosing.

- Is an immediate family member or household member of study personnel

- A history of seizure disorder for which anticonvulsants are currently prescribed
We found this trial at
Meridian, Idaho 83642
Phone: 208-377-8653
Meridian, ID
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7261 Sheridan Street
Hollywood, Florida 33024
Phone: 954-990-7649
Hollywood, FL
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Lenexa, Kansas 66213
Phone: 913-825-4400
Lenexa, KS
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Peoria, Illinois 64614
Phone: 309-672-1910
Peoria, IL
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